AscitesNCT01188746
Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites
A study testing McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire in people with Ascites, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is look at how treatments for ascites affect quality of life. Your quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by cancer, also called malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites
- What is being tested?
- McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with a stage IV malignancy or end-stage disease documented in patient's chart.
- Patients referred to interventional radiology for treatment of refractory ascites with the placement of a permanent catheter including, but not limited to, a Tenckhoff catheter, a PleurX catheter, or a Denver Shunt.
- Fluency in English to enable instrument and interview completion.
- Patients must be at least 18 years of age.
- Patients must be physically capable of completing instruments and/or interview.
- Patients must be able to comprehend and execute informed consent.
Who cannot join
- Unable to complete questionnaire due to a significant physical or mental deficits as assessed by the consenting professional.
- Proxy completion is not accepted
- Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is look at how treatments for ascites affect quality of life. Your quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by cancer, also called malignancy.
All people who participate in this study have ascites associated with cancer. Ascites can cause symptoms that make it difficult for the patient to do simple things. Patients with ascites often report:
Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating. Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this catheter will relieve the symptoms of the ascites. The goal of the investigators study is to understand the quality of life before the procedure and after the procedure. Since the patient is having this procedure to make their symptoms better, the investigators want to hear from the patient of how the procedure has affected their quality of life.
- Conditions
- Ascites
- Being tested
- McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire
- Keywords
- catheter, palliative, quality of life, 10-059
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core QuestionnaireBehavioural
Participants will be interviewed twice (if they chose to participate in the qualitative portion) and complete instruments at three time points: 1) immediately prior to the procedure, 2)within seven days after the procedure, preferably prior to discharge, and 3) three weeks after their catheter placement.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire or interview | Experimental | A pre-experimental design was chosen to examine changes in QoL following a palliative intervention. Receives: Behavioral: McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if there is change in the QoL
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Measured: 2 years
Determine if there is change in symptoms
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Measured: 2 years
Secondary outcomes (2)
Determine the impact ascites has on quality of life
via patient interviews and how this is affected by catheter placement.
Measured: 2 years
Monitor and describe post-catheter placement morbidity and mortality.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piera Robson, RN, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188746
- Sponsor's protocol ID
- 10-059
- Status last verified
- Feb 2020
- First submitted
- 24 Aug 2010
- Last updated
- 6 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites
- ClinicalTrials.gov ID
- NCT01188746
- Acronym / sponsor ID
- 10-059
- Conditions
- Ascites
- Keywords
- catheter, palliative, quality of life, 10-059
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is look at how treatments for ascites affect quality of life. Your quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by cancer, also called malignancy.
All people who participate in this study have ascites associated with cancer. Ascites can cause symptoms that make it difficult for the patient to do simple things. Patients with ascites often report:
Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating. Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this catheter will relieve the symptoms of the ascites. The goal of the investigators study is to understand the quality of life before the procedure and after the procedure. Since the patient is having this procedure to make their symptoms better, the investigators want to hear from the patient of how the procedure has affected their quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire or interview | Experimental | Behavioral: McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core QuestionnaireA pre-experimental design was chosen to examine changes in QoL following a palliative intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with a stage IV malignancy or end-stage disease documented in patient's chart.
- Patients referred to interventional radiology for treatment of refractory ascites with the placement of a permanent catheter including, but not limited to, a Tenckhoff catheter, a PleurX catheter, or a Denver Shunt.
- Fluency in English to enable instrument and interview completion.
- Patients must be at least 18 years of age.
- Patients must be physically capable of completing instruments and/or interview.
Key exclusion criteria (3 listed)
- Unable to complete questionnaire due to a significant physical or mental deficits as assessed by the consenting professional.
- Proxy completion is not accepted
- Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core QuestionnaireParticipants will be interviewed twice (if they chose to participate in the qualitative portion) and complete instruments at three time points: 1) immediately prior to the procedure, 2)within seven days after the procedure, preferably prior to discharge, and 3) three weeks after their catheter placement. | Behavioural | Questionnaire or interview |
Primary outcome
Determine if there is change in the QoL
Time frame: 2 years
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
Determine if there is change in symptoms
Time frame: 2 years
of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
2 secondary outcomes
Determine the impact ascites has on quality of life
Time frame: 2 years
Monitor and describe post-catheter placement morbidity and mortality.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piera Robson, RN principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire in people with Ascites, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if there is change in the QoL (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.